Guidance on Food Traceability, Withdrawals and Recalls within the UK Food Industry

March 2019 For queries about this guidance, including if you require the information in an alternative format such as audio, large print or Braille please contact:

For Scotland: Email: incidents@fss.scot Tel: 01224 285 138

For England, Wales and Northern Ireland: Email: foodincidents@food.gov.uk Tel: 020 7276 8448

## Summary

| Intended audience | ● Food business operators (FBOs)\
| | ● UK food enforcement authorities | | Which UK nations does this cover? | England, Wales, Scotland and Northern Ireland | | Purpose | The purpose of this guidance is to assist FBOs to comply with food law and to provide guidance on roles, responsibilities and actions to take during food safety withdrawals and recalls. | | Legal status: | This guidance sets out the legal requirements of Regulation (EC) No.178/2002 and associated food legislation. The guidance also includes best practice guidance. | | Key words | ● Food law\
| | ● Food withdrawals\
| | ● Food recalls\
| | ● Food safety\
| | ● Traceability | | Review date | March 2020 | Revision history

This guidance follows the Government Code of Practice on Guidance. If you believe this guidance breaches the Code for any reason, please let us know by emailing betterregulation@food.gov.uk. If you have any comments on the guidance itself, please call us using the contact number on page 2.

| Revision No. | Revision date | Purpose of revision and paragraph number | Revised by | |--------------|---------------|------------------------------------------|------------| | | | | |

## Contents

| Section | Page | |------------------------------------------------------------------------|------| | Summary | 1 | | Revision history | 2 | | Introduction | 5 | | Intended audience | 5 | | Purpose and scope of guidance | 6 | | Legal status of guidance | 6 | | EU Exit | 7 | | Definitions | 7 | | Traceability | 8 | | Key steps in developing food traceability systems | 9 | | Making a decision to withdraw or recall food | 11 | | Performing a risk assessment | 13 | | Planning for a food withdrawal/recall | 14 | | Initiating and managing a food withdrawal/recall | 14 | | Information gathering | 15 | | Notification procedures | 15 | | Monitoring progress of a food withdrawal/recall | 16 | | Handling of unsafe food | 16 | | Roles and responsibilities of those involved in a withdrawal/recall | 19 | | FBOs initiating a food withdrawal/recall | 20 | | Non-retail FBOs receiving notification of a food withdrawal/recall | 21 | | Retail FBOs receiving notification of a food withdrawal/recall (including catering businesses selling prepacked food) | 22 | | Caterers receiving notification of a food withdrawal | 23 | | Enforcement authorities | 23 | | Primary and Home authorities (where applicable) | 24 | | Central competent authorities (FSA and FSS) | 24 | | Consumer, allergy and patient support organisations | 25 | | Contents | Page | |------------------------------------------------------------------------|------| | Annexe A: Food Recalls Steering Group and Working Group Members | 26 | | Annexe B: Definitions | 27 | | Annexe C: Specific food traceability requirements | 30 | | Annexe D: Example of microbiological risk assessment considerations | 32 | | Annexe E: Planning for a food withdrawal/recall | 34 | | Annexe E(i): Example contacts template | 37 | | Annexe E(ii): Example food incident key decision log | 38 | | Annexe F: Example template for notifying the enforcement authority | 39 | | Annexe G: Business-to-business communications for food safety withdrawals and recalls across the supply chain | 42 | | Annexe H: Key principles and best practice template for accurate and effective consumer recall notifications | 47 | | Annexe I: Background to root cause analysis | 53 | Introduction

1 This guidance has been produced by the Food Standards Agency (FSA) with Food Standards Scotland (FSS), in association with members of working groups and a governing steering group, established as part of a UK project, to:

- develop comprehensive UK guidance to clarify the roles, responsibilities and expectations of the key players involved in food withdrawals and recalls in the UK
- improve the accessibility and consistency of food recall information directed at consumers
- enhance business to business communications about food recalls and withdrawals and
- establish guidance on root cause analysis (RCA) procedures to be used by industry in the event of food withdrawals and recalls

2 It replaces the FSA Guidance Notes for Food Business Operators on Food Safety, Traceability, Product Withdrawal and Recall produced in 20071.

3 Project group members included representatives from the food industry, trade bodies, consumer, allergy and patient support organisations and enforcement authorities (see Annexe A for membership).

4 FBOs are responsible for the safety of the food which they produce, distribute, store or sell, in particular FBOs must:

- not place unsafe food on the market
- comply with food law in the production, distribution, storage and sale of food
- be able to trace the suppliers of their food and the business customers to whom they have supplied the food (i.e. one step back and one step forward) and
- remove unsafe food from the market should a food safety incident arise

5 FBOs should therefore have adequate traceability and food withdrawal/recall systems in place as part of their Food Safety Management System to fulfil these requirements. FBOs may wish to seek advice from the enforcement authority with whom they are registered or approved, and/or their Primary/Home authority for assurance that any system developed for this purpose is appropriate and compliant.

Intended audience

6 The intended audience of this guidance is FBOs and UK food safety enforcement authorities, as outlined in the definitions.

1 https://www.food.gov.uk/sites/default/files/media/document/fsa1782002guidance.pdf Purpose and scope of guidance

7 The purpose of this guidance is to support FBOs and UK food safety enforcement authorities in establishing and implementing effective food withdrawal/recall systems to respond to food safety incidents. The guidance applies to all FBOs and aims to clarify and, where appropriate, standardise procedures to identify and remove unsafe food from the market.

8 The guidance outlines food law requirements and clarifies the roles, responsibilities and expectations of the key stakeholders involved in the withdrawal/recall of unsafe food in the UK.

9 The guidance sets out the requirements in relation to food safety incidents, in accordance with Regulation (EC) No. 178/2002. It does not include animal feed (including pet food). However, FBOs may wish to adopt the principles within this guidance when dealing with non-safety (non-compliant) related food, food contact materials, or animal feed (including pet food) incidents.

Legal status of guidance

10 This guidance has been produced to explain the legal requirements of Regulation (EC) No.178/2002 in relation to food safety traceability, withdrawals and recalls and how compliance may be achieved. Best practice guidance has also been included. You are not required by law to follow best practice guidance.

11 The guidance is laid out in a format designed to allow businesses to consider their processes and whether their current or proposed arrangements comply with food law. It is laid out in the following format:

- ‘The law’ – this quotes the relevant specific legal requirements. It is detailed at the start of the relevant section
- ‘How to comply with the law’ – this outlines FSA and FSS guidance on how to comply with the law. Businesses may take a different approach to achieve compliance with the law, but it is advisable to discuss any alternative approach with enforcement authorities in advance
- ‘Best practice’ – this outlines examples of good practices that businesses may want to implement. Businesses are not required by law to follow best practice. All guidance on best practice is identified in boxes with a heading of Best Practice:

Best Practice

All best practice guidance is clearly identified within this document by this style of format.

2 https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02002R0178-20180701&qid=1530528430965&from=EN 12. This guidance should be read in conjunction with Regulation (EC) No. 178/2002, the Food Safety Act 1990, associated domestic food law legislation, EU Food Hygiene Regulations, domestic food hygiene regulations and other specific legislation and guidance relating to food traceability and safety.

13. Guidance on legal requirements in this document cannot cover every situation and FBOs may need to refer to the relevant legislation to see how it applies in any given circumstance. FBOs with specific queries may wish to seek advice from their enforcement authorities or seek their own legal advice.

EU Exit

14. References in this guidance to EU law should be read, where necessary, as references to retained EU law as amended under the European Union (Withdrawal) Act 2018.

15. Guidance as to how that Act affects EU law is beyond the scope of this publication. FBOs and enforcement authorities are strongly encouraged to seek independent legal advice about their rights and obligations in connection with the Act, and EU Exit generally.

Definitions

16. A list of definitions of the key terms used throughout this guidance is provided in Annexe B. Traceability

The law

| Legal requirements: Article 18 of Regulation (EC) No. 178/2002 | |---------------------------------------------------------------| | The traceability of food, …food-producing animals, and any other substance intended to be, or expected to be, incorporated into a food …shall be established at all stages of production, processing and distribution. | | Food …business operators shall be able to identify any person from whom they have been supplied with a food, …, a food-producing animal, or any substance intended to be, or expected to be, incorporated into a food … To this end, such operators shall have in place systems and procedures which allow for this information to be made available to the competent authorities on demand. | | Food …business operators shall have in place systems and procedures to identify the other businesses to which their products have been supplied. This information shall be made available to the competent authorities on demand. | | Food …which is placed on the market or is likely to be placed on the market in the Community shall be adequately labelled or identified to facilitate its traceability, through relevant documentation or information in accordance with the relevant requirements of more specific provisions. |

How to comply with the law

17 Each segment of the supply chain must be able to trace all the foods received by them and supplied by them (one step back and one step forward). This will include being able to trace, as required, the ingredients used to produce finished products.

18 In relation to food law, food retailers, including caterers, are not required to keep traceability information relating to sales to the final consumer (since consumers are not food businesses). Where a retailer knows that it is supplying directly to another food business, e.g. a catering outlet, traceability requirements must be adhered to.

19 Business actions necessary to comply with the law will depend on the individual business activities, and what is achievable for the business, but effective traceability allows for effective and efficient corrective actions to be taken should a food safety incident occur. It enables FBOs to target any withdrawals and/or recalls, to give information to enforcement authorities and can help minimise the level of disruption and scale of the withdrawal/recall to the business. Key steps in developing food traceability systems

Step 1. The system The FBO’s system must be able to trace food purchased from suppliers and sold to business customers (this does not include food that is sold directly to the consumer).

Step 2. Defining batches of food Defining batches of food is essential for good traceability and may help limit the amount of food to be withdrawn/recalled. In the event of a food safety incident, Regulation (EC) No. 178/2002 considers a whole batch, lot or consignment unsafe unless it can be demonstrated otherwise.

Step 3. Traceability information Traceability information for food one step back and one step forward in the supply chain is required by law. The following information should be available:

- name and address of supplier/business customer (food retailers, including caterers, are not required to keep traceability information relating to sales to the final consumer)
- details of product, to enable its identification, and quantity in which supplied
- the date of the transaction and delivery

FBOs may choose to keep raw materials in their original packaging to enable retrieval of traceability information.

In addition to the above, all FBOs that handle products of animal origin (POAO) or sprouted seeds must also comply with more specific food traceability requirements. These are outlined in Annexe C.

Step 4. Record keeping To ensure that an effective withdrawal/recall can be implemented in the event of a food safety incident, FBOs must have systems in place which allows traceability information to be made available.

Traceability information can be found on a variety of documents, including invoices, delivery documents or receipts. FBOs should keep this information in a way that makes it easy to check back to see where a product came from and forward to check who has been supplied. Records are not required where the food is supplied directly to the consumer.

Where accurate information can be retrieved quickly it may help minimise the scale of the withdrawal/recall and the impact on public health.

It is for FBOs to determine how long they need to keep traceability information unless specific food regulations state a defined period. The period should be appropriate for the nature and product life span of the food, and the circumstances under which they may be required to produce traceability information.

______________________________________________________________________

7 Commission implementing Regulation (EU) No 931/2011 https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1540286809065&uri=CELEX:32011R0931. Commission Implementing Regulation (EU) No 208/2013 https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1540286887876&uri=CELEX:32013R0208 Best Practice

The system

- It is recommended that FBOs confirm that the suppliers that they trade with also have effective traceability systems and procedures in place.

Traceability information

- Additional information, such as internal process traceability enables better visibility of the FBO’s whole supply chain. Internal traceability systems can assist FBOs in quickly identifying how raw materials and ingredients are stored, used and handled once on site. Examples of process traceability information include:
  - identification of a product batch
  - application of a unique batch code identifier to all packs of that particular batch and internal documentation
  - recording of batch codes of all ingredients used in the production of that batch of product
  - recording of production and quality information relating to the product batch – examples include:
    - product name
    - product batch code
    - date of production
    - time of start and end of production (where appropriate)
    - product size
    - food contact packaging
    - number of packs per case
    - number of cases
    - linking the product batch code to all raw materials used in its production

Record keeping

- Unless there are legal requirements on the minimum period traceability information must be kept, it is best practice to maintain traceability information on pre-packed foods for the shelf life of the food plus 12 months as a minimum. Traceability requirements for foods pre-packed for direct sale, loose foods and foods served as a meal should be considered on a case by case basis, in consultation with the enforcement authority.

Review of traceability systems

- Periodic review of business practices will help ensure that traceability systems remain effective, and that information can be provided in a timely manner. FBOs may wish to carry out a periodic review of their practices. Traceability systems should be reviewed at least on an annual basis, or sooner if there has been a significant change within a business e.g. change of supplier. It is recommended that checks are carried out on supplier and business customer traceability (customer traceability is not required for FBOs selling directly to consumers). Making a decision to withdraw or recall food

The law

Legal requirements: Articles 14 and 19 of Regulation (EC) No. 178/2002

Food shall not be placed on the market if it is unsafe.

In determining whether any food is unsafe, regard shall be had:

(a) to the normal conditions of use of the food by the consumer and at each stage of production, processing and distribution, and

(b) to the information provided to the consumer, including information on the label, or other information generally available to the consumer concerning the avoidance of specific adverse health effects from a particular food or category of foods.

In determining whether any food is injurious to health, regard shall be had:

(a) not only to the probable immediate and/or short-term and/or long-term effects of that food on the health of a person consuming it, but also on subsequent generations;

(b) to the probable cumulative toxic effects;

(c) to the particular health sensitivities of a specific category of consumers where the food is intended for that category of consumers.

In determining whether any food is unfit for human consumption, regard shall be had to whether the food is unacceptable for human consumption according to its intended use, for reasons of contamination, whether by extraneous matter or otherwise, or through putrefaction, deterioration or decay.

If a food business operator considers or has reason to believe that a food which it has imported, produced, processed, manufactured or distributed is not in compliance with the food safety requirements, it shall immediately initiate procedures to withdraw the food in question from the market where the food has left the immediate control of that initial food business operator and inform the competent authorities thereof. Where the product may have reached the consumer, the operator shall effectively and accurately inform the consumers of the reason for its withdrawal, and if necessary, recall from consumers products already supplied to them when other measures are not sufficient to achieve a high level of health protection. How to comply with the law

20 In the event of a food incident, where the food has left the immediate control of the business, FBOs are required to determine if the food is unsafe and whether a withdrawal and/or recall is necessary.

21 The decision tree below outlines a process for establishing if food is unsafe and the necessary actions to take. Businesses are required to inform their enforcement authority where they consider or have reason to believe that the food is unsafe, and so they should have open dialogue with their enforcement authority during this process.

- Where food has not been produced, handled, processed or stored in accordance with food safety legislation the risk assessment should take this into consideration when determining if the food is, or likely to be, unsafe. Performing a risk assessment

22 In some cases, FBOs may be able to easily identify that a food is unsafe due to the exceedance of specified food safety regulatory limits. However, not all hazards that might be found in food are specified in food safety regulations, for example, contamination of food from foreign objects (e.g. glass). The key is that once a hazard of any kind has been identified in food, FBOs should assess the risk it presents to consumers.

23 The assessment of the associated risk should take into account the factors in Article 14 of Regulation (EC) No. 178/2002.

24 FBOs are responsible for carrying out risk assessments and making decisions regarding the safety of the food. Technical expertise may be required in carrying out a risk assessment to understand the hazards involved and the adverse effects that can arise if consumed. FBOs may need to seek advice from technical experts or work with their enforcement authority to either verify their risk assessment or determine the information needed and steps necessary to carry out an effective assessment.

25 A risk assessment should include the following:

- hazard identification: identifying known or potential health effects associated with a particular food
- hazard characterisation: the qualitative and/or quantitative evaluation of the nature of the adverse effect
- exposure assessment: the qualitative and/or quantitative evaluation of the likely intake of the particular food and
- risk characterisation: the integration of hazard identification, hazard characterisation and exposure assessment to estimate the risk and its associated uncertainties

26 As part of the risk assessment, consideration should be given to the intended use of the food, e.g. it is ready to eat, the target consumer group of the food and the potential risk and sensitivities associated with that group in consuming that food.

27 An example of considerations for completing a risk assessment is outlined in Annexe D.

Best Practice

Risk assessment

- Record the outcomes from a risk assessment, the decisions made, and actions taken along with supporting information. Planning for a food withdrawal/recall

28 There are a number of actions that often need to be carried out simultaneously during a food withdrawal/recall, so advance planning is essential. An example of how a food business can plan for a food withdrawal/recall is outlined in Annexe E.

Initiating and managing a food withdrawal/recall

The law

| Legal requirements: Article 19 of Regulation (EC) No. 178/2002 | If a food business operator considers or has reason to believe that a food which it has imported, produced, processed, manufactured or distributed is not in compliance with the food safety requirements, it shall immediately initiate procedures to withdraw the food in question from the market where the food has left the immediate control of that initial food business operator and inform the competent authorities thereof. Where the product may have reached the consumer, the operator shall effectively and accurately inform the consumers of the reason for its withdrawal, and if necessary, recall from consumers products already supplied to them when other measures are not sufficient to achieve a high level of health protection.

A food business operator shall immediately inform the competent authorities if it considers or has reason to believe that a food which it has placed on the market may be injurious to human health. Operators shall inform the competent authorities of the action taken to prevent risks to the final consumer … |

How to comply with the law

29 Where it is necessary to initiate a food withdrawal/recall there are a number of key aspects that need to be considered to manage the process, such as those outlined below. Information gathering

30 Gathering information regarding the food safety incident, including details of the food, the nature of the hazard and the extent of the problem is important so that effective risk management decisions can be made.

31 This information can come from a variety of sources, both internal and external, including:

- production records
- sales records
- employees
- suppliers
- business customers
- audit
- sampling analysis
- complaints and
- enforcement authorities

Notification procedures

32 When FBOs initiate a food withdrawal/recall due to food safety issues, it must be communicated as soon as possible to be effective. A written plan for carrying out a withdrawal/recall will help ensure effective action is taken.

33 FBOs must notify:

- their enforcement authorities and the FSA/FSS
- their suppliers and business customers (including brand owners)
- consumers (only in the case of a recall)

Notification to enforcement authorities and FSA/FSS

34 FBOs are required to notify their enforcement authority and FSA/FSS of a food safety incident if they believe that they have placed food on the market that may be unsafe. This notification information is outlined in a communication template in Annexe F which can be used by FBOs for notifying enforcement authorities.

35 Established reporting mechanisms should be used when notifying FSA/FSS.

36 Notification should not be delayed. If all the information is not readily available, provide what details are available.

Notification to suppliers and business customers

37 FBOs must notify suppliers, where implicated, and affected business customers (including brand owners) of the food incident and the actions to be taken in handling the affected food (e.g.

______________________________________________________________________

8 http://incidents.foodapps.co.uk/login.aspx 9 https://www.foodstandards.gov.scot/business-and-industry/scottish-food-crime-and-incidents-unit/food-incidents/reporting-a-food-incident-guidance return or disposal). Procedures should be set up to outline methods of communication to ensure that unsafe food is removed from the supply chain and recalled from consumers if necessary. Guidance for FBOs on trade to trade communications is outlined in Annexe G.

Notification to consumers 38 Information provided to consumers should be accurate and the communication method effective in informing them of the food recall and action to take. See Annexe H for key principles and best practice templates that may be used when communicating with consumers.

Monitoring progress of a food withdrawal/recall 39 Communication should be maintained between FBOs, enforcement authorities and business customers throughout the incident.

Handling of unsafe food 40 After a food withdrawal/recall, FBOs may have to deal with unsafe food. 41 To ensure the control of food deemed unsafe, FBOs should consider the following: ● storing unsafe food away from non-affected food in a quarantined area ● labelling of quarantined food and ● maintaining accurate traceability and disposal records of recovered unsafe food

Making unsafe food safe 42 It may be possible for FBOs to re-work or re-label unsafe food that makes it safe and compliant with food law, e.g. re-labelling a product with correct allergen information. FBOs must seek agreement from their enforcement authority before any food that has been previously recalled or withdrawn is re-worked or re-labelled.

Disposal of unsafe food 43 If it is not possible to make the unsafe food safe, it must be treated as food waste. If the unsafe food contains POAO, FBOs should deal with it in accordance with the Animal By-Product Regulations(^\\text{10}) or other relevant waste disposal legislation. FBOs should have regard to any required certification that needs completing. 44 For more information on the disposal of waste, FBOs may wish to seek advice from the relevant waste enforcement body(^\\text{11}) or their waste contractor.

______________________________________________________________________

(^{10}) Regulation (EC) No. 1069/2009 https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02009R1069-20140101&from=EN

(^{11}) Animal and Plant Health Agency (APHA) and Local Authorities in England and Wales, DAERA in NI and SEPA in Scotland. Best Practice

Notification procedures

- Consumer, allergy and patient support organisations maintain contact details for vulnerable individuals (e.g. people with a food allergy, intolerance or sensitivity) and can contact these consumers to notify them of recall information. For incidents where food is being recalled due to allergen issues, FBOs should notify the relevant consumer, allergy and patient support organisations, as appropriate.

- Allergy UK (all 14 allergens)(^{12})

- Anaphylaxis Campaign (all 14 allergens)(^{13})

- Coeliac UK (cereals containing gluten - wheat, barley, rye and oats and products thereof)(^{14})

Monitoring progress of a food withdrawal/recall

- In order to monitor the progress of the withdrawal/recall, FBOs could reconcile food removed from the market against known quantities of affected food distributed. It may not be possible to reconcile the full quantity of affected product, however monitoring the quantity of product removed from the market will give information about any additional actions that may be required to re-iterate the messages or to indicate when the withdrawal/recall has been completed.

Handling of unsafe food

- Keep all unsafe food at a central site

Closing a food withdrawal/recall

- The cause of the incident, the level of public health risk and the mitigating action that has been taken to reduce/remove the immediate risk will inform when a food withdrawal/recall can be closed.

Reviewing the food withdrawal/recall

- To assess the effectiveness of a food withdrawal/recall FBOs should carry out a review of their actions. If a food business has developed a food withdrawal/recall plan the review may be done in accordance with its review procedure, but should consider:
  - robustness of the withdrawal/recall plan and procedures
  - effectiveness of communications
  - timeliness of actions taken
  - roles and responsibilities
  - incident key decision log
  - appraisal of decisions made
  - timelines
  - future improvements

(^{12}) https://www.allergyuk.org/ (^{13}) https://www.anaphylaxis.org.uk/ (^{14}) https://www.coeliac.org.uk/home/ Root cause analysis (RCA)

Following a food safety incident, FBOs are advised to undertake a RCA to determine the reason(s) why the food withdrawal or recall occurred. This will enable the identification of corrective actions which, in turn, will help to mitigate reoccurrence of the food safety incident. FBOs can liaise with enforcement authorities in carrying out RCA.

RCA is a method that can be used to determine how and why food safety issues occur, allowing more effective long-term preventative actions to be identified and applied. The analysis performed should identify the initial cause that led to the food withdrawal/recall and the stage at which intervention could be implemented to prevent future recurrence. The findings of the RCA can be used to review the business’s Food Safety Management System (FSMS) to ensure that it remains appropriate and effective. The FSMS is a holistic system of prevention, preparedness and own-check activities to manage food safety and hygiene in a food business, including the traceability and recall of unsafe food.

Background information on RCA is detailed in Annexe I. Roles and responsibilities of those involved in a withdrawal/recall

Legal requirements: Article 19 of Regulation (EC) No. 178/2002

If a food business operator considers or has reason to believe that a food which it has imported, produced, processed, manufactured or distributed is not in compliance with the food safety requirements, it shall immediately initiate procedures to withdraw the food in question from the market where the food has left the immediate control of that initial food business operator and inform the competent authorities thereof. Where the product may have reached the consumer, the operator shall effectively and accurately inform the consumers of the reason for its withdrawal, and if necessary, recall from consumers products already supplied to them when other measures are not sufficient to achieve a high level of health protection.

A food business operator responsible for retail or distribution activities which do not affect the packaging, labelling, safety or integrity of the food shall, within the limits of its respective activities, initiate procedures to withdraw from the market products not in compliance with the food-safety requirements and shall participate in contributing to the safety of the food by passing on relevant information necessary to trace a food, cooperating in the action taken by producers, processors, manufacturers and/or the competent authorities. How to comply with the law

**FBOs initiating a food withdrawal/recall**

45 Any FBO in a food supply chain could be responsible for initiating a food withdrawal/recall, depending on where in the chain the food safety incident is identified. There may be more than one FBO involved and FBOs may need to refer to commercial agreements with brand owners regarding roles and responsibilities.

46 The table below outlines the actions to be taken by FBOs initiating a food withdrawal/recall as a result of a food safety incident:

| Actions | Withdrawal | Recall | |------------------------------------------------------------------------|------------|--------| | Immediately stop supplying the affected food and, if appropriate, notify the supplier | ✔ | ✔ | | Immediately notify their enforcement authority, FSA/FSS and business customers (including brand owners), providing information about the food safety incident, why the food is being withdrawn (if the unsafe food has not yet reached the consumer) or recalled (if the unsafe food has reached the consumer) and action taken/proposed | ✔ | ✔ | | Provide advice to business customers on action to be taken to withdraw/recall food and prevent further supply, which could be in addition to business customers own procedures | ✔ | ✔ | | If appropriate, prepare communication to consumers (i.e. ‘Point of Sale’ (POS) recall notifications for consumers) and send it to all relevant business customers | n/a | ✔ | | Make arrangements with business customers for the return/disposal of the unsafe food in an appropriate manner | ✔ | ✔ | | Ensure unsafe food is clearly identified, handled, re-worked/re-labelled effectively (if salvageable) or disposed of in accordance with corresponding waste requirements | ✔ | ✔ | | Keep all relevant parties informed throughout the withdrawal/recall process | ✔ | ✔ | Non-retail FBOs receiving notification of a food withdrawal/recall

47 Non-retail FBOs receiving notification from another FBO of a food withdrawal/recall may include manufacturers, distributors, importers, wholesalers and brokers (retailers are covered in the section below).

48 The table below outlines the actions to be taken by the receiving non-retail FBOs after notification of a food withdrawal/recall:

| Actions | Withdrawal | Recall | |-------------------------------------------------------------------------|------------|--------| | Liaise with the FBO initiating the withdrawal/recall in relation to the affected food and remove the affected batch of unsafe food from the supply chain, ensuring it is clearly identified and kept separate from non-affected food | ✔ | ✔ | | Contact business customers that have received the affected food from them and provide advice on withdrawal/recall action. This advice should be in line with the information received from the FBO initiating the withdrawal/recall | ✔ | ✔ | | Send POS recall notification to business customers as received from FBO initiating the recall or if appropriate, prepare own POS recall notification | n/a | ✔ | | Return the affected food to the FBO or dispose of it, if requested and in accordance with corresponding waste (taking direction from the FBO who has initiated the withdrawal/recall) | ✔ | ✔ | Retail FBOs receiving notification of a food withdrawal/recall (including catering businesses selling prepacked food)

49 This section is for retailers, where activity is limited to purchasing food products and selling them directly to the consumer. It also includes caterers where prepacked food is sold to take away.

50 Where retailers sell a branded product that is subject to withdrawal/recall, they should co-operate as necessary with the FBO responsible for the management of the incident.

51 The table below outlines the actions to be taken by retailers:

| Actions | Withdrawal | Recall | |------------------------------------------------------------------------|------------|--------| | Remove all unsafe food from sale or supply chain and ensure it is stored separately from other non-affected food | ✔ | ✔ | | Issue POS recall notification to stores (where applicable) and inform consumers of a recall (where appropriate using material provided by FBO initiating the recall) and facilitate the retrieval of the unsafe food | n/a | ✔ | | If appropriate, accept returns of the affected food from consumers, clearly identify and store such food separately from non-affected food | n/a | ✔ | | Return the affected food to the FBO or dispose of it, if requested and in accordance with corresponding waste requirements (taking direction from the FBO who has initiated the withdrawal/recall) | ✔ | ✔ | Caterers receiving notification of a food withdrawal

52 Caterers must ensure that unsafe food is not sold or served to consumers as part of the food service.

53 The table below outlines the actions to be taken by FBOs in relation to food served in service:

| Actions | Withdrawal | Recall | |-------------------------------------------------------------------------|------------|--------| | Ensure that the unsafe food is removed, clearly identified, kept separately from non-affected food and not used in service | ✔ | n/a | | Return the affected food to the FBO or dispose of it, if requested and in accordance with corresponding waste requirements (taking direction from the FBO who has initiated the withdrawal/recall) | ✔ | n/a |

Enforcement authorities

54 Enforcement authorities are responsible for protecting public health and verifying FBO compliance with food law. Enforcement authorities should:

- set up and implement a documented procedure for dealing with food incidents
- provide advice to FBOs in a timely manner to assist in risk assessment and control measures regarding the food safety incident
- provide advice on withdrawal/recall actions to be taken
- check that FBOs have removed affected food from sale and have issued a consumer notification to recall any affected food that has been sold to consumers, as appropriate
- liaise with the Primary/Home authority, if appropriate, in exercising regulatory functions
- oversee the re-working/re-labelling or disposal of the unsafe food (in line with the requirements laid down in the Food Law Code of Practice(^\\text{15}) or the Manual of Official Controls(^\\text{16}) (or equivalent)
- notify FSA/FSS, when required, via FSA/FSS incidents team mailbox, direct contact or FSA/FSS website(^\\text{17})
- ensure that FBOs take action in accordance with any advice issued by FSA/FSS

______________________________________________________________________

(^{15}) England Food Law CoP – https://signin.riams.org/files/display_inline/45497 Wales Food Law CoP – https://signin.riams.org/files/display_inline/48645/Wales-Food-Law-Code-of-Practice---August-2018-02082018.pdf NI Food Law CoP – https://signin.riams.org/files/display_inline/45498 FSS Food Law CoP – https://www.foodstandards.gov.scot/publications-and-research/publications/food-law-code-of-practice-scotland-2019

(^{16}) FSA England and Wales MOC – https://www.food.gov.uk/business-guidance/manual-for-official-controls DAERA VPHP MOC – https://www.daera-ni.gov.uk/publications/manual-official-controls-vphp FSS MOC – https://www.foodstandards.gov.scot/publications-and-research/publications/manual-for-official-controls

(^{17}) England – FoodIncidents@food.gov.uk / Tel: 020 7276 8448, Wales – Wales.FoodIncidents@food.gov.uk / Tel: 02920 678961, NI – incidents.ni@food.gov.uk / Tel: 02890 417700, Scotland – incidents@fss.scot / Tel: 01224 288379 FSA website – http://incidents.foodapps.co.uk/login.aspx FSS website – https://www.foodstandards.gov.scot/business-and-industry/scottish-food-crime-and-incidents-unit/food-incidents Roles and responsibilities of those involved in a withdrawal/recall

55 Enforcement authorities are responsible for taking the appropriate enforcement action if FBOs are not complying with food law. In accordance with Article 54 of Regulation (EC) No. 882/2004(^{18}), enforcement authorities have the power to order a withdrawal/recall of a food if FBOs do not fulfil their legal obligations regarding the safety of food. The authority also has the power to detain, seize and dispose of food deemed unsafe.

Primary and Home authorities (where applicable)

56 The role of a Primary(^{19})/Home authority is to:

- work in partnership with FBOs or with a co-ordinator supporting a group of FBOs (e.g. trade associations) to co-ordinate their regulation and support compliance, including providing advice when dealing with food incidents
- act as a key point of contact in respect of a Primary/Home authority partner FBO and source of information for FBOs, co-ordinators and local authorities
- provide support to local authorities to determine actions to be taken when dealing with food incidents
- guide local authorities on how they interact with partnering FBOs

Central competent authorities (FSA and FSS)

57 FSA and FSS have the responsibility for public health protection and are the central competent authority for food safety in the UK. FSA and FSS have a role in:

- co-ordinating national and international food withdrawals/recalls – being the central point of contact
- co-ordinating activities in the case of unsafe food being exported from the UK to other countries
- liaising with relevant enforcement authorities/Primary or Home authority regarding food withdrawals/recalls
- where appropriate, liaising with FBOs involved in food safety withdrawal/recall and co-ordinating response when multiple FBOs are involved
- liaising with other relevant stakeholders, as required, during food incidents
- overseeing the risk assessment and risk management of food safety incidents, where appropriate
- providing information to the public about the food recall on its website, via email/SMS alert and social media
- where appropriate, providing information to the public about a food safety withdrawal

(^{18}) Regulation (EC) No. 882/2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules – https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02004R0882-20180701&qid=1545159845271&from=EN

(^{19}) https://www.legislation.gov.uk/ukpga/2008/13/contents Consumer, allergy and patient support organisations

58 Consumer, allergy and patient support organisations have a role to play in ensuring their members/supporters are kept informed on issues of interest to them, including food incidents that may pose a risk to their health.

59 On receipt of a notification of a food recall relating to their area of interest, consumer, allergy and patient support organisations can:

- issue an email alert to signed up members/supporters
- provide information on the food recall and necessary action on their website
- publish information about the food recall on social media

Best Practice

FBOs initiating a food withdrawal/recall

| Actions | Withdrawal | Recall | |------------------------------------------------------------------------|------------|--------| | If appropriate, prepare additional communications material e.g. Q&A for consumers and send it to all relevant business customers | n/a | ✔ | | Check that the information has been received by business customers, and action is being taken to withdraw/recall the food | ✔ | ✔ | | Maintain appropriate records and monitor the withdrawal/recall process | ✔ | ✔ | | Carry out a review to determine the cause of the food safety incident (e.g. RCA) and implement corrective measures that may be shared with the enforcement authority | ✔ | ✔ | | Review the effectiveness of the withdrawal/recall and document the outcomes and any action points | ✔ | ✔ |

Enforcement authorities

Where FBOs have carried out a review to determine the cause of the food safety incident and have implemented corrective actions, verify that this has been done and share the information with FSA/FSS Annexe A: Food Recalls Steering Group and Working Group Members

Acknowledgement is given to the following organisations that were involved in the development of this guidance as members of the Food Recalls Steering Group and/or Working Groups:

- Aberdeen City Council
- Allergy UK
- Anaphylaxis Campaign
- Anthony, Rowcliffe & Son
- Argyll and Bute Council
- Asda
- Association of Convenience Stores
- Bart Ingredients
- Belfast City Council
- Braintree District Council
- BRC Global Standards
- British Federation of Frozen Foods
- British Retail Consortium
- Cambridge City Council
- Campden BRI
- Chartered Institute of Environmental Health
- Chartered Trading Standards Institute
- Chilled Foods Association
- City of Edinburgh Council
- Coeliac UK
- Co-op
- Cranswick Foods
- Cropwell Bishop Creamery
- Department for Business, Energy Industrial Strategy
- Federation of Wholesale Distributors
- Food and Drink Federation
- Food Standards and Labelling Focus Group
- Fresh Produce Consortium
- Gluten Free Industry Association
- Greencore
- GS1
- Mendip District Council
- Mondelez
- Morning Foods
- National Food Hygiene Focus Group
- Neals Yard Dairy
- Nestlé
- Ocado
- Oscar Mayer
- Pepsico
- Premier Foods
- Provision Trade Federation
- SALSA
- Scottish Food Enforcement Liaison Committee
- Southwark Council
- Specialist Cheese Makers Association
- Tesco
- UK Hospitality
- Which?
- Wrexham County Borough Council
- Wycombe District Council Annexe B: Definitions

This annexe outlines the definitions of the key terms set out in the guidance document.

‘brand’ – a product manufactured by a FBO under a particular name in order to define it in the eyes of the consumer

‘business customer’ – a food business who buys food from another food business

‘central competent authority’\* – the central authority of a Member State competent for the organisation of official controls or any other authority to which that competence has been conferred; it shall also include, where appropriate, the corresponding authority of a third country

‘consumer’ – anyone that consumes food or obtains food for their own domestic use

‘consumer, allergy and patient support organisation’ – an organisation that has a role in keeping their members/supporters informed of relevant food safety issues. Examples include Coeliac UK, Allergy UK and Anaphylaxis Campaign

‘durability date’\*\* – the date of minimum durability of a food until which the food retains its specific properties when properly stored

‘enforcement authority’ – the authority which is responsible for enforcing food law. For registered businesses this will be the local or port health authority where the establishment is registered. For approved businesses it will be the authority that granted the approval

‘food’\*\*\* or (‘foodstuff’) – any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans. ‘Food’ includes drink, chewing gum and any substance, including water, intentionally incorporated into the food during its manufacture, preparation or treatment. It includes water after the point of compliance as defined in Article 6 of Directive 98/83/EC and without prejudice to the requirements of Directives 80/778/EEC and 98/83/EC

‘Food’ does not include:

(a) feed (b) live animals unless they are prepared for placing on the market for human consumption (c) plants prior to harvesting (d) medicinal products within the meaning of Council Directives 65/65/EEC and 92/73/EEC (e) cosmetics within the meaning of Council Directive 76/768/EEC (f) tobacco and tobacco products within the meaning of Council Directive 89/622/EEC (g) narcotic or psychotropic substances within the meaning of the United Nations Single Convention on Narcotic Drugs, 1961, and the United Nations Convention on Psychotropic Substances, 1971 (h) residues and contaminants For the purposes of this guidance the term food has been further categorised:

- **‘prepacked food’** – food and the packaging into which it was put before being offered for sale, whether such packaging encloses the food completely or only partially, but in any event in such a way that the contents cannot be altered without opening or changing the packaging

- **‘prepacked for direct sale’** – food that is packed at the same premises from which it is being sold

- **‘loose food’** – food that is sold or displayed without packaging – for example, ice cream displayed in a freezer and served into a tub

**‘food business’** – any undertaking, whether for profit or not and whether public or private, carrying out any of the activities related to any stage of production, processing and distribution of food

**‘food business operator’** (FBO) – the natural or legal persons responsible for ensuring that the requirements of food law are met within the food business under their control

**‘food (safety) incident’** – any event where, based on the information available, there are concerns about actual or suspected threats to the safety of food that could require intervention to protect consumers' interests

**‘food law’** – the laws, regulations and administrative provisions governing food in general, and food safety in particular, whether at Community or national level; it covers any stage of production, processing and distribution of food

**‘food safety management system’** – a systematic approach to controlling food safety hazards within a food business in order to ensure that food produced is safe to eat

**‘food withdrawal/recall plan’** – a written document detailing a food business’ food withdrawal/recall system for withdrawing or recalling unsafe food

**‘hazard’** – a biological, chemical (including allergens) or physical agent in, or condition of, food with the potential to cause an adverse health effect

**‘home authority’** – a scheme set up to help businesses in the UK to comply with legislation by providing advice, guidance and information. It assists businesses that have outlets in more than one local authority area

**‘placing on the market’** – the holding of food for the purpose of sale, including offering for sale or any other form of transfer, whether free of charge or not, and the sale, distribution, and other forms of transfer themselves

**‘primary authority’** – as provided for in section 23A of the Regulatory Enforcement and Sanctions Act 2008, is a local authority that has formed a partnership with a business or co-ordinator and is nominated by the Secretary of State to exercise certain functions through that partnership. This currently only applies in England and Wales

**‘product batch’** – a defined quantity of product processed in one process or series of processes so that it could be expected to be homogeneous

**‘products of animal origin’** (POAO) –

- food of animal origin, including honey and blood live bivalve molluscs, live echinoderms, live tunicates and live marine gastropods intended for human consumption and

other animals destined to be prepared with a view to being supplied live to the final consumer

‘recall’ – the process by which unsafe food is removed from the supply chain and consumers are advised to take appropriate action, for example to return or dispose of the unsafe food

‘retail’\*\*\* – the handling and/or processing of food and its storage at the point of sale or delivery to the final consumer, and includes distribution terminals, catering operations, factory canteens, institutional catering, restaurants and other similar food service operations, shops, supermarket distribution centres and wholesale outlets

‘retail activities’ can be further categorised and defined in this guidance as:

- ‘food retailers’ – businesses that sell food to consumers, such as supermarkets and e-commerce, but covers any other business that sells or gives food to consumers whether for profit or not
- ‘catering’ – all businesses providing food to consumers, including pubs, restaurants, leisure businesses, cafés, hotels, fast food and take-away outlets, mobile vendors, public sector catering and food service sector

‘risk’\*\*\*\* – a function of the probability of an adverse health effect and the severity of that effect, consequential to a hazard

‘risk assessment’\*\*\*\* – a scientifically based process consisting of four steps: hazard identification, hazard characterisation, exposure assessment and risk characterisation

‘risk management’\*\*\* – the process, distinct from risk assessment, of weighing policy alternatives in consultation with interested parties, considering risk assessment and other legitimate factors, and, if need be, selecting appropriate prevention and control options

‘root cause analysis’ (RCA) – an assessment to determine the initiating cause of the food safety incident

‘sprouted seeds’ – the product obtained from the germination of seeds and their development in water or another medium, harvested before the development of true leaves and which is intended to be eaten whole, including the seed – e.g. fenugreek seeds

‘traceability’\*\*\* – the ability to trace and follow a food, feed, food-producing animal or substance intended to be, or expected to be incorporated into a food or feed, through all stages of production, processing and distribution

‘unsafe food’\*\*\*\* – food that is considered to be injurious to health or unfit for human consumption

‘withdrawal’ – the process by which unsafe food is removed from the supply chain, where unsafe food has not yet reached the consumer

- Definition laid down in Regulation (EC) No. 882/2004 \*\* Definition laid down in Regulation (EU) No. 1169/2011 \*\*\* Definitions laid down in Regulation (EC) No. 178/2002 † Definition laid down in Regulation (EC) No. 853/2004 Annexe C: Specific food traceability requirements

In addition to the mandatory traceability requirements as outlined in Regulation (EC) No. 178/2002, all FBOs that handle product of animal origin (POAO) or sprouted seeds must make the following information available to the enforcement authority on demand:

**Products of animal origin (POAO)**

- an accurate description of the food
- the volume or quantity of the food
- the name and address of the FBO from which the food has been dispatched
- the name and address of the consignor (owner), if different from the FBO, from which the food has been dispatched
- the name and address of the FBO to whom the food is dispatched (if applicable)
- the name and address of the consignee (owner), if different from the FBO, to whom the food is dispatched (if applicable)
- a reference identifying the lot, batch or consignment, as appropriate and
- the date of dispatch (if applicable)

**Sprouted seeds**

- an accurate description of the seeds or sprouts, including the taxonomic name of the plant
- the volume or quantity of the seeds or sprouts supplied (if applicable)
- where the seeds or sprouts had been dispatched from another FBO, the name and address of: (i) the FBO from which the seeds or sprouts have been dispatched (ii) the consignor (owner) if different from the FBO from which the seeds or sprouts have been dispatched
- the name and address of the FBO to whom the seeds or sprouts are dispatched (if applicable)
- the name and address of the consignee (owner), if different from the FBO to whom the seeds or sprouts are dispatched (if applicable)
- a reference identifying the batch, as appropriate and
- the date of dispatch (if applicable)

This additional information is not required for sprouted seeds after they have undergone a treatment that eliminates microbiological hazards. Traceability information of products of animal origin and sprouted seeds must be updated daily.

FBOs handling certain food products of animal origin, e.g. fish products and beef may also be required to comply with specific traceability and labelling requirements laid down in sector specific legislation. Annexe D: Example of microbiological risk assessment considerations

Points that may be considered in microbiological risk assessments

**NOTE:** this is not an exhaustive list of all points that need to be included in a risk assessment and not all points may be applicable/relevant, as it will depend on the type of food safety incident.

**Hazard identification**

- definition of the hazard and the food product(s) it is linked to
- levels of the hazard present in the food and notable results from laboratory reports
- species and/or serotype if known and relevant

**Exposure assessment**

- the population at risk and whether any particular groups, including vulnerable groups, are of particular concern
- dose consumed
- prevalence of contamination in the batch
- shelf-life of product(s) involved and potential for frozen storage which would extend shelf-life
- any cooking instructions and whether these would be sufficient to destroy the hazard
- any other processing or handling of the product which could increase or decrease risk
- cross-contamination potential
- distribution; large or small scale, and types of establishments the affected food product is sent to
- quantities of the affected food product that has been sold/used
- possibility of other batches or products being affected

**Hazard characterisation**

- symptoms caused by hazard and severity of illness or injury
- incubation period
- infectious dose
- dose-response relationship ● evidence of outbreaks/illness associated with hazard (and food product)

**Risk characterisation**

● combining the qualitative or quantitative information of the previous components to produce a risk estimation and estimation of overall uncertainty

● the probability and severity of illness or injury occurring, taking into account the given population(s)

● list of uncertainties

Further information can be found at: https://www.who.int/foodsafety/risk-analysis/riskassessment/en/ Annexe E: Planning for a food withdrawal/recall

It is recommended that FBOs develop a food withdrawal/recall plan as part of their Food Safety Management System. It can help FBOs when dealing with food incidents and can include procedures and documentation that can facilitate an effective food withdrawal/recall.

An example of a food withdrawal/recall plan may include procedures and documentation such as:

- list of team members involved in implementing the plan
- definition of team member roles and responsibilities
- contact details
- risk assessment and notification procedures
- communication templates
- food incident log
- review and testing procedures

Establishing a team to deal with food withdrawals/recalls

Depending on the size and complexity of the food business, there may be one or more people involved in dealing with food withdrawals/recalls. The following areas of the business could be represented, where applicable: It may be the case that some of the above inputs will be provided from outside the business, e.g. legal advice and expert technical help. The team would likely be responsible for managing food withdrawals/recalls and developing, implementing, managing, evaluating and updating the withdrawal/recall plan.

**Team roles and responsibilities**

To ensure the effective withdrawal/recall of unsafe food, all team members (including deputies) involved in managing food safety incidents should be clear about their roles and responsibilities, which can be detailed in the food withdrawal/recall plan. An example of roles and responsibilities is outlined below.

| Business owner | Overall oversight and responsibility | |-------------------------|--------------------------------------------------------------------------------------------------------| | Production | Identify batch | | | Cease production | | | Identify raw materials affected/implicated | | | Identify finished products affected | | Quality/technical | Carry out food safety risk assessment | | | Notify enforcement authorities and FSA/FSS | | | Root cause analysis | | Engineering/ maintenance| Carry out any necessary repairs | | | Regular serving/maintenance | | Planning | Maintain up to date procedures | | | Mock incident exercises | | Purchasing | Identify and contact suppliers of raw materials/affected product | | Accounts | Arrange reimbursement, if applicable | | | Seek reimbursement, if applicable | | Sales/marketing | Contact business customers and advise how food should be handled | | | If necessary, arrange for pick up at retail outlets | | Legal | Handle legal issues | | Distribution | Block affected stock and stop distribution | | | Carry out traceability and prepare inventory and distribution details | | | Establish if product has reached consumer | | | Arrange returns and/or disposal of affected stock | | Public relations/media | Handle communication and media queries | | | Place media adverts and press releases | | | Other PR activities, as needed | Contacts list

It is important that an up to date contact list of internal and external contacts is maintained by FBOs, which can be included in the food withdrawal/recall plan. FBOs should take into account data protection requirements for obtaining, storing, handling and disposing of personal data.

The following contact details are examples of what should be recorded (main contacts plus deputies):

- senior management
- team members dealing with food incidents
- suppliers of all food
- business customers
- hauliers/depots/cold stores
- sources of technical advice and support
- enforcement authorities
- consumer organisations

It is often the case that food incidents occur outside of normal business hours, so out of hours contact details may be important to retain. An example contact list is outlined in Annexe E(i).

Risk assessment and notification procedures

FBOs should develop procedures for conducting risk assessments and notifying the relevant parties as part of the withdrawal/recall plan.

Communication templates

FBOs may wish to produce templates for communicating with enforcement authorities, suppliers and business customers and consumers. Editable communications templates are published separately along with this guidance. Examples can be found in Annexes F, G, and H.

Food incident key decision log

A food incident key decision log is a useful document for food businesses to capture all relevant information regarding a food withdrawal/recall and the rationale for decisions made. An example log can be found in Annexe E(ii). FBOs should log details of the incident, food product(s), conversations, decisions made, and actions taken. Communications can be logged by the team/person managing the incident and kept within the withdrawal/recall plan.

Review and testing of food withdrawal/recall plan

A way of ensuring that suitable systems and procedures are in place to deal with a food safety incident is to carry out a periodic review and testing of the business’s plan and procedures. FBOs should review a food withdrawal/recall plan and its procedures on an annual basis. This could include an incident mock exercise, involving business customers (including retailers), as it is easier to challenge and audit the plan following a mock exercise than during a real-life situation.

## Annexe E(i): Example contacts template

| Name and organisation | Address | Contact numbers (including out of hours) | Email | |------------------------|---------|------------------------------------------|-------| | Supplier 1 | | Tel: Mobile: Fax: | | | Supplier 2 | | Tel: Mobile: Fax: | | | Supplier 3 | | Tel: Mobile: Fax: | | | Business customer 1 | | Tel: Mobile: Fax: | | | Business customer 2 | | Tel: Mobile: Fax: | | | Business customer 3 | | Tel: Mobile: Fax: | | | Enforcement Authority | | Tel: Mobile: Fax: | | | Consumer organisation 1| | Tel: Mobile: Fax: | | Annexe E: Planning for a food withdrawal/recall

Annexe E(ii): Example food incident key decision log Date

38

Time

Activity (Action, Communication, Decision)

Name of contact

Guidance on Food Traceability, Withdrawals and Recalls within the UK Food Industry

Description

Annexe F: Example template for notifying the enforcement authority

Food Incident Report Form for FBOs notifying enforcement authorities

(notifications to FSA/FSS should be made using online form)

**Food business name and address:**

**Food business operator (FBO) details:**

| Name of FBO | | |-------------|---| | Contact details (business hours) | Telephone: | | | Email: | | | Fax: | | Contact details (out-with business hours) | Telephone: | | | Email: |

**Description of food safety incident:**

**Description of product:** Annexe F: Example template for notifying the enforcement authority

Type of Product:

Product Name:

Brand Name:

Batch Code(s)/Durability date(s):

Product Size and type of packaging:

Country of Origin of food:

Distribution details:

Manufacturer details (including contact details): Import/Export details (including contact details):

List of business customers supplied to:

Quantities, batch codes and pack sizes sent to each customer:

When food first placed on the market and has food reached consumer:

Details of risk assessment (if applicable) and action (including justification) for dealing with incident:

Any additional information: Annexe G: Business-to-business communications for food safety withdrawals and recalls across the supply chain

Overview

Effective communication within the supply chain is essential for ensuring a successful food withdrawal/recall. Each point in the supply chain has a responsibility for effective and timely communications to their business suppliers and business customers.

It is key for FBOs to have a good communications plan in place to ensure the intended audience is reached.

This best practice guidance is aimed at food businesses trading with business customers (i.e. businesses purchasing and supplying food for sale to consumers in store or online). The guidance applies at each point in the supply chain when food is being withdrawn for food safety reasons and when food is ultimately being recalled from the consumer.

Examples of business customers can include:

- wholesaler/distributor including where appropriate hauliers, storage depots and coldstores
- retailers
- catering sector
- contract catering
- national accounts
- third party agencies
- exporters where affected product may go for export or sale in third countries

Guidance for FBOs initiating a food withdrawal/recall

Responsibility for the withdrawal or recall communications should be taken by a nominated individual. A nominated deputy should also be identified.

The point of contact at each business customer will differ but could include:

- business owner
- responsible senior managers
- technical services
- account managers
- third party agent FBOs initiating the withdrawal/recall should use traceability and/or sales information to help identify suppliers (if relevant) and those business customers who have received affected product.

A communications plan, which can form part of the business’s withdrawal/recall plan, should be put in place setting out which business customers will be contacted, how they will be contacted and with what messages, including the relevant action to take.

This plan should identify what information is to be provided to business customers, where it is available and should include, where appropriate:

- product (including product description)
- size, weight and packaging format (which distinguishes the affected product from similar products or formats not affected i.e. 100g not 200g etc)
- batch codes affected
- other product identifying codes
- durability dates, including use by or best before
- reason for withdrawal or recall (including where recalls are occurring, any available ‘Point of Sale’ notices)
- information about where to find batch/date code (e.g. photograph or location of the code on the pack, possibly including cases)
- instruction on next steps (e.g. take off sale/return or securely dispose of)
- contact details – who to contact for more information, or where to return affected product

FBOs should also advise their business customers that where there is further onward distribution of affected product, they should communicate to their own customers that a withdrawal/recall is underway and request that appropriate action is taken to cascade the withdrawal/recall action.

Communication should be timely, clear, concise, factual, easily understood and includes action to take. Pictures should be used where possible, showing the product packaging and the location of the product identifying code.

Communications could be direct or via a third-party agency. A single approach may not be effective in all cases.

Methods of communication could include:

- email (if email is being used for communication, read receipts should be turned on)
- telephone (if supported by one of the other methods of communication)
- letter
- via trade association Key elements of the communication, and a suggested template, is outlined below:

| ACTION REQUIRED | |-----------------| | PRODUCT WITHDRAWAL/RECALL [Specify] NOTIFICATION |

| Product Name and Description (including pack size): | Product A, 100g (e.g.) | |-----------------------------------------------------|------------------------| | Product Identifying Code (eg EAN Code): | 12345 | | Product type: | Retail grocery | | Reason for notification: | Incorrect allergen labelling | | Type of packaging, possibly including wholesale case or traded unit: | | | Accurate and up to date pictures of product and location of batch code, possibly including pictures of wholesale case or traded unit: | | | Full Batch code information: | | | 1. Pack | 123 (located…) | and, where different: | | | 2. Pallet | 456 (located …) | 3. Case | 789 (located …) | 4. Pack | | | Action required by when: | Contact business customers and initiate withdrawal/recall process (specify action by customer channel if different) | Include POS template, where required | Return affected product to xxxx | | | Contact information: | xxx@producta.co.uk | | Ask for the Withdrawal Team on 020 124 4567 | | PRODUCTA@PRODUCTA.CO.UK | | We will respond to your query as soon as we are able | Guidance for FBOs receiving notification

A clear plan should be in place by business customers which can be used should a withdrawal or recall need to be actioned.

FBOs should use their traceability/sales transactions systems to identify products purchased, at what time, what quantities and by whom.

Business customers should be advised on the withdrawal/recall action though contact by one or more of the following methods:

- email (if email is being used for communication, read receipts should be turned on)
- telephone (if supported by one of the other methods of communication)
- letter
- advertisement in trade press (only as a supporting mechanism)
- signage at point of sale in depot.

FBOs who are notified of a food withdrawal/recall should also advise their business customers that where there is further onward distribution of affected product, they should communicate to their own customers that a withdrawal/recall is underway, and that appropriate action is required to cascade the communication.

Key elements of the communication, and a suggested template, is outlined below: Dear x

(Company or Brand Name) are currently initiating a Product Withdrawal/Recall\* for the Product A 100g. You have been identified as purchasing/receiving the affected products. No other products from Company or Brand Name are affected by this withdrawal/recall\*.

We apologise for the inconvenience caused.

- Select appropriate option

| Product Name and Description (including pack size): | Product A | |---------------------------------------------------|-----------| | Product Identifying Code (and EAN/barcode information if appropriate): | 123456 | | | Barcode 001234567890 | | Supplier: | Product A | | Pack Size: | 100G | | Pictures of product, including wholesale case: | | | Best Before/Use by Date: | XX/XX/XXXX | | Batch Code (and location on case/consumer unit): | Pallet | | | Case | | | Pack | | Reason for withdrawal/recall: | Incorrect allergen labelling | | Action required by when: | Contact business customers and initiate withdrawal/recall process | | | Include POS template, where required | | | Return affected product to xxxx | Annexe H: Key principles and best practice template for accurate and effective consumer recall notifications

Businesses are recommended to follow this guidance when communicating food recalls to consumers.

Research has established that there are a number of ways to communicate food recall messages to consumers, so that they can make informed choices about products they have bought which are unsafe. Point of sale notices have been identified through the research as a key way of communicating food recalls to consumers. The different aspects to consider in creating effective recall messages include:

- style and appearance
- necessary content
- effective channels for communicating recall messages to consumers, including best location for displaying point of sale notices

Style & Appearance

Communication that grabs the attention of consumers makes it easier for them to identify what the communication is and what it means for them.

| Communication should be: | For example: | |-----------------------------------|-----------------------------------------------------------------------------| | Clear and easy to read | ● Simple layout | | | ● Large, legible font that can be read easily | | | ● Headings and sub-heading for longer notices | | Bright and eye catching | ● Use red colour and iconography (exclamation mark) associated with alert and risk if possible | | | ● Use of banners, boxes and bordering to draw attention | | Concisely worded | ● Lay out information in clear, simple language with use of bullet points | Necessary Content

Communicating the right information will help consumers clearly identify the unsafe product and what to do if they have bought it.

| Recall information should include: | For example: | |-----------------------------------|-------------| | The reason for recall | ● Use clear title to indicate what this is and what the danger or risk to consumers is | | Product details | ● Brand and product name(s) | | | ● Pack size(s) | | | ● Durability dates of affected product(s) | | | ● Batch code(s) | | How to identify the product(s) | ● Where the durability or batch code information is found on the packaging | | Product image | ● A clear picture, preferably in colour | | | ● Where multiple products are affected, pictures should be presented vertically with the associated product details aligned | | Clear direction on what consumers should do if they have bought the product | ● Do not eat this product | | | ● Return the product to the store where you bought it from | | | ● How to obtain a refund | | Where to go for more information | ● A contact number that consumers can contact for more information | The research conducted has shown consumers prefer language that is simple and easily understood. Examples of suggested wording include the following:

| Reason for alert | Suggested wording | |-------------------------------------------------------|-----------------------------------------------------------------------------------| | Confirmed contamination of product with salmonella/listeria monocytogenes/E.coli etc | “X product” is being recalled because salmonella/listeria monocytogenes/E.coli etc has been found | | Inadequate procedures to control Clostridium botulinum | “X product” is being recalled because of concerns over procedures to control Clostridium botulinum | | Confirmed contamination of product with foreign objects | “X product” is being recalled due to the presence of “foreign object” | | Allergens not mentioned on the product label | “X product” is being recalled because it contains “allergen ingredient” which is not mentioned on the label. This means the product is a possible health risk for anyone with “coeliac disease\*/an allergy to/an intolerance to/a sensitivity to” “allergen” |

There will be occasions when food is recalled because the food business has reason to believe that food placed on the market is unsafe, but there are uncertainties as follows:

- the recall is being undertaken on the basis of a presumptive (and not confirmed) result
- there are issues which reduce the confidence in sampling or laboratory analysis and/or
- there is uncertainty around contamination of all recalled batches

In these instances, the food business may wish to use wording as indicated below:

| Reason for alert | Suggested wording | |-------------------------------------------------------|-----------------------------------------------------------------------------------| | Possible contamination of product with salmonella/listeria monocytogenes/E.coli etc | “X product” is being recalled as the product may contain salmonella/listeria monocytogenes/E.coli etc | | Possible contamination of product with foreign objects | “X product” is being recalled which may contain “foreign object” |

The wording advice stated above should not be used in any incident where product is known to be contaminated. This includes product being recalled as part of a batch that is considered unsafe, in line with the Article 14 (6) of Regulation (EC) No 178/2002. Effective Channels of Communication

Consumers expect to be notified of recalls via a number of channels to ensure widespread awareness. Examples of these include the following:

| Communication channels: | Detail: | |--------------------------------------------------|-------------------------------------------------------------------------| | In-store point of sale notice | Located in a position where they are: | | | ● Prominent and visible | | | ● In colour | | | ● Eye-level | | Examples of locations include: | | | | ● At the tills | | | ● At customer service desks | | On retailer’s website | ● For example, displayed on a dedicated product recalls web page | | Via social media | ● Shared through social media channels by the recalling businesses | | Via retailer loyalty card schemes (if applicable)| ● For example through communication channels such as text/e-mail alerts | | Consumer, allergy and patient support organisations | ● For example, displayed on website/social media and through other communications channels such as text/e-mail alerts |

To assist businesses in communicating food recalls in-store, examples of completed point of sale notices are provided below. Editable point of sale notice templates for are available at: https://www.food.gov.uk/business-guidance/food-incidents

www.foodstandards.gov.scot/food-recalls-guidance Food Recall Alert Salmonella Alert

The Generic Co, Generic Salted Crisps.

We are recalling our Generic Salted Crisps because salmonella has been found in them.

The Generic Co, Generic Salted Crisps Pack sizes, batch codes and best before dates affected: Pack Size: 25g Batch Code: AB1234 Best Before Date: 30/11/2018

The batch code and best before date can be found on the back of the packaging at the bottom right corner.

⚠️ What you should do

If you have bought Generic Salted Crisps as detailed above, do not eat them. Instead:

- Check if you have bought the affected batch code and best before date of Generic Salted Crisps.
- You can do this by taking a picture of this notice or writing down the batch code and best before date for reference at home.
- Return the product to the store for a full refund (with or without a receipt).

Want more information?

For more information contact us on 01234 567890 or e-mail generic.co@generic.com

Date: 05/01/2019 Allergy Alert

Allergen - Egg

The Generic Co, Generic Salted Crisps

We are recalling a batch Generic Salted Crisps because they contain egg which is not mentioned on the label. This means it is a possible health risk for anyone with an allergy to egg.

The Generic Co, Generic Salted Crisps Pack sizes, batch codes and best before dates affected: Pack Size: 25g Batch Code: AB1234 Best Before Date: 30/11/2018

The batch code and best before date can be found on the back of packaging at the bottom right hand corner.

⚠️ What you should do

If you have bought Generic Salted Crisps as detailed above and you have an allergy to egg, do not eat them.

Instead:

- Check if you have bought the affected batch code and best before date of Generic Salted Crisps.
- You can do this by taking a picture of this notice or writing down the batch code and best before date for reference at home.
- Return the product to the store for a full refund (with or without a receipt).

Want more information?

For more information contact us on 01234 567890 or e-mail generic.co@generic.com

Date: 05/01/2019 Annexe I: Background to root cause analysis

Root Cause Analysis (RCA) is based on the principle that problems are best solved by attempting to identify and eliminate the root causes of an outcome, as opposed to merely addressing the immediately obvious symptoms.

If performed successfully, RCA identifies the initiating cause in a causal chain which leads to an outcome or effect of interest. Commonly, root cause is used to describe the depth in the causal chain where an intervention could reasonably be implemented to change performance and prevent an undesirable outcome.

RCA can influence the approach to problem solving encouraging desired behaviours that are proactive rather than reactive. As such it is believed that RCA can be used to determine how and why food safety issues occur, allowing more effective long-term preventative actions to be identified and applied.

Different tools can be used when performing RCA, the oldest, and perhaps simplest, is the ‘5 whys’. The development of this process was originally attributed to Sakichi Toyoda, and later utilised by the Toyota Motor Corporation, this technique requires an investigator to ask a series of ‘why’ questions. Each time a cause is identified, the question ‘why did it happen?’ is applied until the root cause is identified.

The principles of RCA have long been recognised in fields such as the petrochemical industry, environmental management, aviation and vehicle accident investigation, and engineering. Key UK governmental organisations, including the National Health Service (NHS), the Health & Safety Executive (HSE), and the Department for Environment, Food & Rural Affairs (DEFRA) all routinely make use of RCA. BRC Global Standards also recognises the use of RCA in their Global Standard for Food Safety.